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Process validation protocol – Operational qualification template

An Operational Qualification template, also known as an Operational Qualification, is used to complete the process validation protocol by collecting all required data such as calibration equipment, training records and user manuals, and displaying the results of checkpoints, alarms and output data. Use this template to define specific plant/system challenges such as standard conditions and worst-case situations for your validation plan. Lab managers can also take advantage of a customizable Tablet Compression Checklist SOP to ensure that lab personnel take the right steps when using the tablet press.

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Process Validation Protocol - Operational Qualification Template
Operational Qualification Protocol
Goal:
Scope of the Operational Qualification Protocol:
Responsibility and responsible person/people/team(s)
Materials, Equipment, Documents
Preparation
List of Calibration Devices/Tools Required
Calibration Process
Calibration Time
Apparatus/Instrument
Document Validation
SOP Name and Number
File Location
QA/QC Approval Date
Training Reports
Name of the emplyee
Select Date and Time:
Course on SOP#
Equipment
Their Make and Model
Is a handbook accessible to everyone?
Results
Control Point(s) and Alarm(s)
Control Point(s) /Alarm(s)
Result
Date
Outputs
Explain the output
Result
Date
Calibration of Equipment/System
Explain the Calibration SOP
Result
Date
Specific Challenge of the Equipment or System
Test in usual conditions
Test of worst case szenario:
Completion
Operational qualification results:
Conclusions:
Name and signature of the protocol author :
Departmental approval by (name and signature):
Quality assurance approval by (name and signature):
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Please note that this checklist template is a hypothetical appuses-hero example and provides only standard information. The template does not aim to replace, among other things, workplace, health and safety advice, medical advice, diagnosis or treatment, or any other applicable law. You should seek your professional advice to determine whether the use of such a checklist is appropriate in your workplace or jurisdiction.
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